1 Preparation of Standard Paneled Plasma for HBV, HCV, and HIV-1 in Japan Hisao Yugi Japanese Red Cross Central Blood Center Study Group of the Ministry.

Slides:

Advertisements

Similar presentations

NAT testing in Poland E. Brojer, M. Łętowska, A

Advertisements

Development of a Panel for Dengue Virus Maria Rios, PhD CBER/FDA Blood Products Advisory Committee Meeting December 14, 2010.

HBsAg+ candidate blood donors HBV genotypes Number Origin(s) A1 43 S. Africa A2 72 Poland B 126 Hong Kong Malaysia Taiwan Thailand C 90 Hong Kong Malaysia.

Yi-Chen Yang, Drug Biology Division Bureau of Food and Drug Analysis Department of Health, Taiwan Collaborative study for establishment of the first national.

Karen Cristiano Biologicals Unit, CRIVIB Calibration against the WHO Standards of National Reference Preparations for detection of blood viruses by NAT:

Linearity Panels HIV RNA, HCV RNA, HBV DNA, and CMV DNA

Evaluation of Rapid Screening Methods for Emergency Blood Collections CPT Robert.

I.1 ii.2 iii.3 iv.4 1+1=. i.1 ii.2 iii.3 iv.4 1+1=

I.1 ii.2 iii.3 iv.4 1+1=. i.1 ii.2 iii.3 iv.4 1+1=

F. Kourgia, M. Vini, E. Zervou

Testing Source Plasma for Hepatitis B Virus by Nucleic Acid Testing Blood Products Advisory Committee Meeting Blood Products Advisory Committee Meeting.

R Diagnostics June 19, 2003 WNV FDA BPAC MeetingPCR NAT Blood Screening TaqScreen West Nile Virus Program - Roche Update James L. Gallarda, Ph.D. Roche.

Prevalence and risk relationships of tattoo, acupuncture and skin/body piercing histories among American Red Cross blood donors Sharyn Orton, MSPH, PhD.

PROFICIENCY TESTING OF IN-HOUSE NAT ASSAYS USED FOR BLOOD SCREENING XXI SoGAT International Working Group Meeting on the Standardization of NAT for the.

Limitations of HBsAg testing in the screening of blood donors Wolfram H. Gerlich Institute of Medical Virology University Giessen, Germany SoGAT XVI Langen.

Lookback study for transfusion- related HBV infection in Japan Tokyo Metropolitan Red Cross Blood Center Masahiro Satake.

Pooled Source Plasma NAT for HIV-1 An Update from the Bayer HIV-1 IND Study Barbara Masecar Bayer Corporation Raleigh, NC Blood Products Advisory Committee.

Faculty of Allied Medical Sciences Clinical Immunology & Serology Practice (MLIS 201)

BioLife Plasma Services Experience with HBV NAT Testing

Organ Donor Infectious Disease Testing Education UW Health OPO July 2009.

1 HBV Genotype Panel Michael Chudy Section of Molecular Virolgy Division of Virology SoGAT XXI Meeting Brussels, May 2009.

Reentry for Donors Deferred Based on Anti-HBc Test Results November 3, 2005 BPAC Meeting FDA/CBER/OBRR/DETTD.

IN THE NAME OF GOD Blood Safety S. AMINI KAFI ABAD CLINICAL AND ANATOMICAL PATHOLOGIST IRANIAN BLOOD TRANSFUSION ORGANIZATION(IBTO) RESEARCH CENTER June.

Update on the Replacement of the HCV RNA International Standard Sally Baylis & Alan Heath, NIBSC SoGAT XX, Warsaw June 2007.

SOGAT Validation of HCV-RNA detection in small test pools on cadaveric samples Marco Koppelman #, Theo Cuypers #, Mirjam de Waal #, Maarten.

CE MARKING OF IVDDs - the NIBSC perspective Morag Ferguson Division of Virology.

EQASs for Blood Borne Virus Genomes and BSE Prions from Cattle Brain and INSTAND Reference Materials H.-P. Grunert 1,2, K.-O. Habermehl 1,2, V. Lindig.

Occult hepatitis B virus (HBV) and hepatitis C virus (HCV) viremia in women with and at-risk for HIV/AIDS Taylor L, Gholam P, Delong A, Rompalo A, Klein.

Stability of HCV, HIV-1 and HBV nucleic acids in plasma samples stored at different temperatures Marta José, Rodrigo Gajardo and Juan I. Jorquera Instituto.

Yi-Chen Yang, Yu-Hsuan Chen, Show-Lan Chiu, Hwei-Fang Cheng Drug Biology Division, Bureau of Food and Drug Analysis Department of Health, Taiwan, ROC National.

SoGAT XVII/Paris, 2004 Proficiency Testing of In-House Developed HIV-1 NAT for Blood Screening Michael Chudy, Paul-Ehrlich-Institut Division of Virology,

SoGAT June 14, 2006 HCV-RNA and HIV-RNA detection in small test pools of cadaveric samples for viral safety of tissue transplants Maarten Koot#,

HBV screening Further improvement of blood safety based on the knowledge deduced from the results on analysis of the donor’s sera positive for HBV DNA.

W W W. Q I A G E N. C O M Dirk Heckel, PhD Diagnostic Sample Preparation and Stabilization QIAGEN GmbH.

Blood Products & related Biologicals: SoGAT, 28 May 09 1 |1 | Dr Ana Padilla, Blood Products & related Biologicals Essential Medicines and Pharmaceutical.

Update on the P. falciparum Standard & Replacement of the HBV & HCV International Standards Sally Baylis, NIBSC SoGAT XIX.

Natural history of HBV infection (adapted from Torbenson Lancet 2003) Chronic infection Healthy carriage Recovery occult DNA Anti-HBe Anti-HBc Immune response.

NUCLEIC ACID AMPLIFICATION TECHNOLOGY HCV-RNA / HBV-DNA / HIV-RNA testing blood and blood components for transfusion Italian External Quality Assessment.

Management of Donors and Units that Test HBV NAT Positive: Current Considerations July 21, 2005 BPAC Meeting Robin Biswas, M.D. FDA/CBER/OBRR/DETTD.

Elisa Moretti Process and Analytical Development KEDRION S.p.A SoGAT XVI Paul Ehrlich Institut - Langen, Germany 3 rd July 2003 Automated Extraction for.

Preparation of HBV DNA reference standards and the experience of HBV NAT in Taiwan Dr. Hwei-Fang Cheng Department of Health, Taiwan.

Serology - anti-HCV. anti-HIV, HBsAg NAT - HCV RNA - since 2000

Ro / BSD Hessen Institut für Transfusionsmedizin SoGAT XVII, Paris, Paris 2004 B19 Overview of Testing for Blood Banks W. Kurt Roth Red Cross Blood Transfusion.

An Overall View of Standardization May 26, 2004 Indira Hewlett, Ph.D. CBER/FDA.

Epidemiology of Transfusion Transmitted Disease Sharyn Orton, MT(ASCP)SBB, M.S.P.H, Ph.D. candidate Project Leader, Transmissible Diseases Department American.

E B—Anti-HBc Chart 1 10/2004 Anti-HBc Testing and Donor Reentry Results of a Pilot Study Susan L. Stramer, Ph.D. American Red Cross Blood Products.

CBER Update on status of West Nile virus test, lot release and validation panel development Indira Hewlett, Ph.D CBER/FDA Blood Products Advisory Committee.

Informational Presentation: WHO Biological Standards Summary of January 29-30, 2007 WHO Meeting with WHO Collaborating Centres for Biological Standards.

Seroprevalance of Hepatitis C in Turkey (%) (Anti-HCV positivity in donors) Adana (n:8310) Antalya (n:16.410) Bursa (n:16.512) Erzurum (n:24.870) İstanbul.

False negative HBsAg detectionFalse negative HBsAg detection n Is rare in patients with signs of chronic hepatitis B. n May be an issue in low-risk populations,

Hepatitis B Virus Quantitation 진단검사의학과 정유진

Saeko Mizusawa, Yoshiaki Okada

Abbott HCV core Ag and HCV RNA Comparison Study

In The Name of God.

TRANSFUSION: Blood donation and preparation of blood components

GRIFOLS PLASMA: genotype 2 vB19 sample

Harvey Holmes, Clare Morris and Neil Berry Division of Retrovirology

Organ Donor Infectious Disease Testing Education

Results of Recent EQA Panels for Blood Borne Viruses

Preparation of plasmids containing HBV-full genome of genotype A to H and trial of HBV inactivation method Yoshiaki Okada Kiyoko Umemori Kazunari.

Factor xiiia enzyme Human Factor XIII is cleaved with human alpha thrombin. The thrombin is subsequently removed via chromatography. The above protein.

Evaluation data on the new Roche cobas s 201 system with the cobas TaqScreen MPX test Lutz Pichl, Volkmar Schottstedt German Red Cross Blood Transfusion.

Evaluation of Candidate Standard XX (97/650)

Italian EQA study for HCV RNA, HIV RNA and HBV DNA G. M. Bisso, K

Viral Safety of Blood Products in Taiwan

به نام خداوند بخشنده مهربان

Trust is good, control is better!

SoGAT meeting XXI May (2009), Brussels, Belgium

ANALYTICAL CONTROL SYSTEM AS A MEASURE TO ENSURE INFECTIOUS SAFETY OF HUMAN PLASMA FOR FRACTIONATION A.L. Poptsov FSBI “ROSPLASMA” RMSPC of FMBA of RUSSIA.

Presentation transcript:

1 Preparation of Standard Paneled Plasma for HBV, HCV, and HIV-1 in Japan Hisao Yugi Japanese Red Cross Central Blood Center Study Group of the Ministry of Health, Labour and Welfare, Japan

2 Objectives For standardizations and specifications of the NAT and serological test For evaluation of reagents To achieve the safety of blood products

3 Contents Virus :HBV, HCV, HIV-1 Fresh frozen plasma from voluntary donated bloods Source : Panels :100 panels each including negatives undiluted fresh frozen plasma from each donors Test Items :NAT and serological tests

4 Test Items HBV DNA TaqMan PCR(J), AMPLICOR HBV Monitor(R) GenotypeDNA sequencing Subtypededuced from sequence IgM anti-HBcLumipulse(F) anti-HBsAUSAB(A), Lumipulse(F) anti-HBc AxSYM(A), Lumipulse(F), HBcAb ELISA(O) DNA sequencingPre-C mutation HBsAg PRISM(A), AxSYM(A), ARCHITECT(A), Lumipulse(F), Vitros(O), HBsAg ELISA(O) Methods/Reagents (A):Abbott, (F):FUJIREBIO, (J):JRC, (O):Ortho, (R):Roche HBV Panels

5 ABCDFABCDF HBV genotypeNumber early stage:51 late/carrier stage:42 HBV Panels HBV DNAHBsAganti-HBcNumberCategory Positive Negative Positive Negative Positive Negative Positive Negative I II III IV V

6 HBV Panels

7

8 Test Items HCV RNA TaqMan PCR(J), AMPLICOR HCV Monitor(R) GenotypePCR anti-HCV PHA(A), PA(F), Lumipulse(F), AxSYM(A), HCV Ab ELISA(O) Methods/Reagents (A):Abbott, (C):Chiron, (F):FUJIREBIO, (J):JRC, (O):Ortho, (R):Roche HCV Panel HCV core AgLumipulse(F), HCV Ag ELISA(O), HCV Ag IRMA(O) Lumipulse(F)anti-HCV core RIBA(C)WB

9 Preliminary Application Study A nation-wide survey for HCV NAT Coded panel for the survey - Genotype 1b, 2a, 2b ( IU/mL) - Negative plasma Participants: - COBAS AMPLICOR : 92 HPs and Labs - AMPLICOR (MWP) : 32 HPs and Labs

10 Result False negative result - 1b:2.4% (3/124) - 2a:6.5% (8/124) - 2b:2.4% (3/124) - Neg:0.0% (0/124) 11 sites gave false negative results 9 with COBAS, 2 with MWP Improvement ==>> No false negative nor positive result in 11 sites in the follow-up survey

11 Hisao Yugi Shigeru Tamatsukuri Norio Yahagi Tohru Yamada Hidetaka Minakawa Retsuji Yamanaka Shunji Iida Harumichi Matsukura Masaaki Mizui Mitsunobu Imai Teruhide Yamaguchi Hiroshi Yoshizawa Chief JRC Central B.C. Roche Diagnostics K.K. Ortho-Clinical Diagnostics K.K. Abbott Japan Co. Ltd. FUJIREBIO Inc. JRC Headquarter JRC Osaka B.C. JRC Hiroshima B.C. Kanagawa Pref. Public Health Lab. National Inst. Health Sci. Hiroshima Univ. Graduate School Biomed. Sci. Study group on the establishment of standardizations, specifications and test methods for the safety and quality of blood products under the Ministry of Health, Labour and Welfare, Japan